Explained: Why Covaxin Continues To Struggle With WHO's Emergency Nod

Apart from being asked for more data from the WHO, lesser doses than guessed earlier, controversies in Brazil and other countries not recognising the vaccine continue to plague Bharat Biotech.

The World Health Organisation's Technical Advisory Group recently announced that it is likely to take a decision on the application by Covaxin for emergency use listing on November 3. This is the third time that the group has delayed the decision and asked Bharat Biotech, the manufacturer of Covaxin to provide additional data.

As its emergency use listing decision is still pending, many countries are not accepting those who received two doses of the indigenous inactivated virus vaccine as fully vaccinated. The vaccine recipients have to follow the rules for the unvaccinated and observe stringent quarantine requirements as mandated by the international countries.

However, the WHO has not shared the specifics of data and documents sought by them from Bharat Biotech.

This is not the first time that Covaxin is being discussed for data anomalies. Since last year, the vaccine has been under spotlight for its transparency and data issues. The vaccine produced in collaboration with the Indian Council of Medical Research and the National Institute of Virology was mired in controversy when it was shared that clinical trials for the vaccine would be fast tracked to be completed by August 15, 2020. The ICMR later backtracked and said that it would not compromise with the quality of the product and was referring to the first two phases of the clinical trials.

Bharat Biotech, the manufacturer, is one of the leading vaccine manufacturers in the country. Prior to Covaxin, it has rarely been in the spotlight for regulatory disturbances. With Covaxin, it has been pulled up for lack of production, seeking people for trials without consent, rejection by the US FDA, turmoil with the Brazil government.

WHO's Emergency Use Listing Seeks More Data

Bharat Biotech approached the WHO for clearing Covaxin for emergency use listing back in June 2021. Since then, the WHO has met three times to discuss Covaxin's approval. The meeting scheduled on October 5 asked for more data. After the meeting held this week, the TAG again stated that it required more data and said it would reconvene on November 3.

Neither WHO nor Bharat Biotech has shared what is the data that the WHO seeks from the vaccine manufacturer.

BOOM spoke to Dr. Vineeta Bal, virologist, Indian Institutes of Science Education and Research, Pune, to understand what could have gone wrong with the EUL process and why Covaxin continues to find itself embroiled in one controversy after the other.

"Bharat Biotech is one of the big players in vaccine manufacturing in the country. However, this time around there is barely any transparency. What ails the current regulatory process is all speculative," Bal stated.

The virologist also added that it is not merely limited to the clinical trial data when it comes to the emergency use listing by the WHO. "We do not know yet but it could also be related to the technical know-how and the products that have been used to inactivate the whole virus. The WHO knows about a set of products and may have wanted more data. Nothing is clear, yet," Bal added.

Whether Covaxin receives emergency use listing or not will be now determined on November 3. If Covaxin does receive approval, it will open the doors of international travel to the recipients. Currently, many countries only accept vaccines that have been approved by the WHO.

Bharat Biotech Does Not Meet Promised Production

After receiving emergency use authorisation on January 4, Bharat Biotech began ramping up its production capabilities. However, the government has always overestimated the manufacturer's production capacity.

While Bharat Biotech produced close to 90 lakh doses every month which was augmented to two crore doses in May, the company as well as the government promised that Bharat Biotech would produce close to 10 crore doses a month by September. However, Bharat Biotech failed to meet this deadline.

By August-September, the company raised its production capacity to five crore doses and in November with the help of other public sector units, it might be able to achieve the 10 crore doses per month mark. Bharat Biotech plans to manufacture doses at its own Hyderabad, Bengaluru, Pune, and Ankleshwar sub units. It has also signed deals with three PSUs- Bharat Immunologicals and Biologicals Corporation (BIBCOL), Haffkine Bio-Pharmaceutical Corporation, Mumbai, and Indian Immunologicals (IIL), Hyderabad, in the second half of this year.

"The government knew that even though huge, BB's production capacity is not comparable to Serum Institute of India's capabilities. Inactivating a whole live virus requires a Biosafety Lab of Level 3 which is not easily accessible. This contributes to the delay in production of the vaccine, " Bal explained.

Currently, of the three PSUs only IIL has started production and both Haffkines and BIBCOL need to upgrade their labs to meet the manufacturing lab criteria. The Bengaluru plant faced delays and the Ankleshwar unit is also slowly gaining speed.

"The company is increasing its production but unlike an adenoviral vaccine, producing an inactivated virus vaccine takes longer and is more detail oriented. The government should have thought about it earlier and sanctioned these PSUs earlier, " Bal said.

Covaxin which was touted to be the hero in India's fight against COVID-19 along with the Oxford-AstraZeneca Covishield vaccine produced by the Serum Institute of India. Although India has given over 102 crore doses, they are skewed more in the favour of Covishield. On the other hand, only 9.5-10 crore of Covaxin doses have been administered. Covaxin is the most expensive vaccine currently available in the country.

Controversies In Brazil and US

Ocugen, an American vaccine manufacturer, that was Bharat Biotech's partner in the US had applied for an EUA with the American Food and Drug Administration. The FDA rejected the application on the grounds that it needed more data from the manufacturers.

After the dismissal, Covaxin has not been recognised as a valid COVID-19 vaccine and people who have been vaccinated have to follow the quarantine mandate. They may also have to get re-vaccinated with an approved vaccine or take the Johnson and Johnson, Moderna or Pfizer vaccines available in the US. Once Covaxin receives EUL from the WHO, there is a possibility that the US might accept it.

In Brazil, Bharat Biotech got accused of participating in fraudulent practices and was pulled by the Brazil courts. After the Brazilian government suspended a $324 million deal, Bharat Biotech ended its deal with the country as the situation got murkier and even involved Bolsonaro, the Brazilian President. The government even cancelled its vaccine trials.



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